FDA's PADAC supports approval of BREO ELLIPTA as once-daily inhaled treatment for COPD

Published on April 18, 2013 at 6:05 AM · No Comments

GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of  BREO ELLIPTA™ as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against). 

BREO ELLIPTA™, is the proposed proprietary name for FF/VI 100/25 mcg, a combination of the inhaled corticosteroid (ICS) fluticasone furoate "FF" and the long acting bronchodilator (LABA) vilanterol "VI" (FF/VI).

The FDA Advisory Committee also voted that the safety of FF/VI 100/25 mcg once daily in COPD has been adequately demonstrated for the proposed indications (10 for, 3 against).

Patrick Vallance , GSK's President of Pharmaceuticals, R&D, said: "We are pleased with the outcome of today's meeting.  COPD is a debilitating and progressive disease. Its symptoms are often severe and can have a huge impact on patients' lives. This positive recommendation is a crucial first step towards making BREO ELLIPTA available for appropriate COPD patients across the US. We look forward to a final decision from the FDA later this year."

"After a decade of development in this programme, our collaboration with GSK is one step closer to providing an important therapeutic option to COPD patients," said Rick E Winningham, Chief Executive Officer of Theravance. "We are proud to collaborate with GSK on the development and potential commercialisation of treatments for COPD and other respiratory diseases. The panel's positive recommendation of BREO ELLIPTA represents an important achievement in a transformative year for Theravance."

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